Enteric Fever | Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever
Enteric Fever research study
What is the primary objective of this study?
The investigators aim to compare two antibiotic treatments for enteric (typhoid) fever. Three hundred patients at Patan Hospital will be enrolled in the study. Patients will be assigned to one of the two treatments by chance and followed for 6 months. The two treatment groups will be compared to see which treatment is more likely to make the patient better.
Who is eligible to participate?
Inclusion Criteria: - Suspected or culture proven enteric fever - >= 2 <= 45 years of age - Fever >= 38°C for >= 4 days - Informed consent to participate in the study Exclusion Criteria: - Pregnancy - Obtundation - Shock - Visible jaundice - Presence of signs of gastrointestinal bleeding - Evidence of severe disease - Diabetes - History of hypersensitivity to either of the trial drugs - Known previous treatment with a quinolone antibiotic or 3rd generation cephalosporin or macrolide within one week of hospital admission.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Ceftriaxone≥2-<14 years - 60mg/kg/ once daily for 7 days 14 years and older - 2g once daily for 7 days Intravenous infusion. Vials of crystalline powder.
Drug:GatifloxacinGatifloxacin 10 mg/kg/day for 7 days. Tablets for oral administration.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
GatifloxacinGatifloxacin 10mg/kg/day for 7 days
Ceftriaxone≥2-<14 years - 60mg/kg/ once daily for 7 days 14 years and older - 2g once daily for 7 days
Start Date: September 2011
Completed Date: January 2015
Phase: Phase 4
Primary Outcome: Rate of treatment failure
Secondary Outcome: S.typhi or S.paratyphi carriage
Study sponsors, principal investigator, and references
Principal Investigator: Buddha Basnyat, MD
Lead Sponsor: Oxford University Clinical Research Unit, Vietnam
Collaborator: University of Oxford